Cartridge holder for automated reprocessor

ABSTRACT

A cartridge holder ( 30 ) for an automated endoscope reprocessor ( 10 ) is mounted on a movable rack ( 14 ). As the rack is wheeled into the chamber, a connector ( 164 ) on the cartridge holder ( 164 ) automatically makes a fluid connection with a connection port ( 158 ) within the chamber. The cartridge holder includes a base ( 42 ) and a lid ( 44 ), which is pivotally connected to the base by a hinge ( 110 ). A cartridge ( 40 ) holding a dose of a disinfectant concentrate or reagents is positioned in a well ( 50 ) defined by the base and the lid closed. Water flows through the cartridge holder via a fluid passageway (A) defined in part by the lid and in part by the hinge. The water mixes with the concentrate or reagents and the resulting disinfectant solution passes out of a lower end ( 205 ) of the cartridge into the well. The solution flows upwardly, around the cartridge, through an annular space ( 232 ) between the cartridge and the well, disinfecting the well in the process. The solution exits the cartridge through a plurality of bores ( 80 ) at an upper end of the base.

BACKGROUND OF THE INVENTION

[0001] The present invention relates to the field of disinfection orsterilization of medical, pharmaceutical, dental, or mortuary devices,and the like. It finds particular application in conjunction with acartridge holder for a disinfectant or sterilant concentrate for use inthe cleaning and disinfecting of flexible endoscopes, and will bedescribed with particular reference thereto. It should be appreciated,however, that the invention is also applicable to the treatment of otherdevices.

[0002] Fluid microbial decontamination systems are typically designed tocause microbes on the item to be removed or killed by a fluidanti-microbial agent. This is achieved in a variety of ways, includingbath of anti-microbial liquid, spraying the item with anti-microbialliquid, surrounding the item with anti-microbial vapor, and the like.

[0003] Liquid microbial decontamination systems are now widely used forequipment which could not withstand the high temperatures of steamsterilization. Commonly, a technician mixes a liquid disinfectant orsterilant composition, such as peracetic acid or other strong oxidant,and manually immerses the items to be microbially decontaminated in thecomposition. The high degree of manual labor introduces numerousuncontrolled and unreported variables into the process. There arequality assurance problems with technician errors in the mixing ofsterilants, control of immersion times, rinsing of residue, exposure tothe ambient atmosphere after the rinsing step, and the like.

[0004] To deliver reproducible amounts of sterilants to the microbialdecontamination system, a number of packaging systems have beendeveloped. One problem to overcome is that cleaning agents, such asdetergents, and pretreatment agents, such as buffers and corrosioninhibitors, tend to degrade peracetic acid. Combining them with liquidperacetic acid results in a reduced shelf life. Thus, for peraceticsterilants, in particular, such components of a treatment system aregenerally kept separate to prolong shelf life. U.S. Pat. No. 5,037,623to Schneider, et al., for example, discloses a cup which contains ameasured dose of a liquid peracetic acid concentrate. Buffers,detergents, and anticorrosive agents, in the form of a powder, areseparately contained. The cup includes a linear vent passage whichextends into the interior of the cup. A gas permeable membrane ismounted over the interior end of the vent passage to allow venting ofthe container during storage.

[0005] U.S. Pat. No. 5,662,866 to Siegel, et al. discloses atwo-compartment cup for powdered sterilant reagent components. An outercompartment holds a first reagent while an inner compartment, disposedwithin the outer compartment, holds a second reagent. The two reagentsreact in water to form an oxidant, such as peracetic acid. Pretreatmentagents, such as surfactants, corrosion inhibitors, and sequesteringagents, are often included in one of the two compartments. Peripheralwalls of inner and outer cups are affixed together at flanges adjacenttheir open ends to define the two compartments. A permeable sheet isaffixed to the inner cup flange for ventedly sealing both cups. Theouter cup is closed at its base by a first detachable base and the innercup is similarly closed by a second detachable base.

[0006] To release the sterilant into the fluid flow path of a microbialdecontamination system, the cup is inserted into a well in fluidcommunication with the system. In the case of the liquid sterilant cup,a peel-off top is removed to provide access to the contents of the cup.Alternatively, a cutter, such as that disclosed in U.S. Pat. No.5,439,654 to Kochte, pierces the base of the cup with a blade. In thecase of the powdered sterilant cup with a removable base, pressure isapplied to detach the bases of the inner and outer cup portions.Minerovic, et al., U.S. Pat. Nos. 5,997,814 and 6,325,968, discloses twocompartment cups in which parts of the cup are formed from a permeablematerial, allowing the contents of the cup to pass through whendissolved in water. A jet stream of water is sprayed into the cup todissolve and flush the sterilizing agents from the cup.

[0007] In general, the water enters the top of the well, flows throughthe cup, and passes out of the well though an opening in the bottom. Thewalls of the well adjacent the sides of the cup, receive reduced contactwith the sterilant or disinfectant. In cases where the devices beingsterilized or disinfected are heavily contaminated with blood and otherbiological materials, biofilm may build up on the walls of the well. Thebiofilm could support microbes during periods of non-use. Rinse waterpassing through the well may occasionally pick up a portion of thisbiofilm, leading to recontamination of the devices.

[0008] The present invention provides for a new and improved cartridgeholder for holding a multi-compartment cup, which overcomes theabove-referenced problems and others.

SUMMARY OF THE INVENTION

[0009] In accordance with one aspect of the present invention, adecontamination system is provided. The system includes a chamber forreceiving an item to be decontaminated. A cartridge holder is mountedwithin the chamber, which receives a single use cartridge containing aconcentrated decontaminant or reagents which mix with water to form adecontaminant solution. The cartridge holder includes a base, whichdefines a well having an opening through which the cartridge is insertedinto the well. A lid selectively closes the well opening. A plurality ofbores adjacent an upper end of the well fluidly communicate between thewell and the chamber, such that water entering the well is directedfirst through the cartridge before exiting the well through the bores. Afluid distribution system is fluidly connected with the cartridge holderfor supplying the water to the well.

[0010] In accordance with another aspect of the present invention, acartridge holder is provided. The cartridge holder includes a base,which defines a well for receiving a cartridge having a sidewall. Thebase has an opening adjacent an upper end thereof. The base includes aplurality of bores, which extend from the well to an exterior surface ofthe base adjacent the opening. A lid selectively closes the opening. Afluid passageway is at least partially defined by the lid and is fluidlyconnected with the well.

[0011] In accordance with another aspect of the present invention, amethod of disinfection is provided. The method includes placing acartridge in a well defined by a base through an opening in the well.The cartridge has a sidewall and upper and lower ends which selectivelyhold within the cartridge a disinfectant concentrate or reagents whichreact in a liquid to form a disinfectant solution. The method furtherincludes closing the opening in the well with a lid and supplying theliquid to the well. The liquid is flowed into the cartridge through theupper end such that the liquid mixes with the concentrate or reagents toform the disinfectant solution. The disinfectant solution is flowed outof the cartridge into the well through the lower end of the cartridge.The disinfectant solution is flowed through a space between thecartridge sidewall and the well to disinfect the well. The disinfectantsolution is flowed out of the well through a plurality of bores in thebase adjacent an upper end of the well. Items to be disinfected arecontacted with the disinfectant solution.

[0012] One advantage of at least one embodiment of the present inventionis that sterilizing or disinfecting fluid is circulated over allsurfaces of a cartridge holder, assuring that the cartridge holder ismicrobially decontaminated.

[0013] Another advantage of at least one embodiment of the presentinvention is that an operator is able to establish whether a cartridgehas been used without opening the cartridge holder.

[0014] Another advantage of at least one embodiment of the presentinvention is that the cartridge holder acts as a manifold for gaseousand liquid passages, reducing the number of fluid connections which areto be made by an operator.

[0015] Another advantage resides in improved dissolving of powderedreagents.

[0016] Still further advantages of the present invention will becomeapparent to those of ordinary skill in the art upon reading andunderstanding the following detailed description of the preferredembodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The invention may take form in various components andarrangements of components, and in various steps and arrangements ofsteps. The drawings are only for purposes of illustrating a preferredembodiment and are not to be construed as limiting the invention.

[0018]FIG. 1 is a side sectional view of an automated reprocessoraccording to the present invention;

[0019]FIG. 2 is a perspective view of a rack of the reprocessor of FIG.1 supporting a cartridge holder and two endoscope head containersaccording to the present invention;

[0020]FIG. 3 is a rear perspective view of a rack of the reprocessor ofFIG. 1 supporting a cartridge holder according to the present invention;

[0021]FIG. 4 is an enlarged perspective view of the cartridge holder ofFIG. 1, with its lid opened to reveal a cartridge;

[0022]FIG. 5 is an enlarged perspective view, in partial section, of thecartridge holder of FIG. 1;

[0023]FIG. 6 is an enlarged perspective view of the cartridge holder ofFIG. 1, with its lid opened showing the cartridge being positioned in abase of the cartridge holder;

[0024]FIG. 7 is an enlarged side sectional view of the cartridge holderof FIG. 1, with its lid in a closed position; and

[0025]FIG. 8 is an enlarged side perspective view of the cartridgeholder of FIG. 1, with its lid in a closed position and the endoscopehead container open to receive an endoscope.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] With reference to FIG. 1, an automated reprocessor 10 defines aninterior chamber 12, which receives a wheeled cart or rack 14. Items tobe disinfected or otherwise decontaminated, such as endoscopes or othermedical, dental, pharmaceutical or mortuary devices, and the like, arepositioned in open baskets or shelves 16 of the cart 14. The cart 14wheels into or out of the interior chamber 12 along tracks 18,positioned one adjacent each side of the chamber. A door 20 selectivelycloses an access opening 22 to the chamber. The reprocessor chamber 12is preferably 10-15 liters in interior volume, allowing the reprocessorto be sized to fit under counters or other work surfaces. However,higher installation locations and other sized processors are alsocontemplated.

[0027] While the reprocessor 10 is described herein with particularreference to disinfecting and rinsing steps, it is also contemplatedthat additional steps are employed, such as a precleaning step.Additionally, while disinfection, which refers to the destruction orinactivation of all harmful microorganisms, is generally desired, it isalso contemplated that higher levels of antimicrobial treatment areachieved, such as sterilization (the destruction or inactivation of allmicroorganisms, whether harmful or not), or lower levels, such assanitization. The various levels of microbial decontamination can beachieved by adjusting the selected chemical agent, concentration of thechemical agent, cycle time, and the like.

[0028] With reference also to FIGS. 2-4, a cartridge holder 30 ismounted on the illustrated cart 14 by a mounting bracket 32, usingscrews, bolts, or other fixing members 34. In a preferred embodiment,the mounting bracket 32 is attached to an upper rear portion 36 of thecart 14 such that it faces a rear wall 38 of the chamber 12 (FIG. 1).

[0029] The cartridge holder 30 receives a cartridge or cup 40, which inthe preferred embodiment, holds a measured dose of a concentrated sourceof a decontaminant, such as a disinfectant or sterilant. The source maybe in liquid or solid form and is sealed within the cartridge 40 untiluse. The cartridge holder 30 includes a base 42, a lid 44, and amounting member 46, through which the screws 34 are attached to thecartridge holder. The mounting member 46 is mounted to the base 42 byscrews 48, or other suitable fixing members (FIG. 5). The lid 44, base42, and mounting member 46 are advantageously formed from a rigidplastic, for example by molding, with inserts 49, formed from metal orother hard material which is capable of being tapped for receiving thescrew threads.

[0030] While the cartridge holder 30 is advantageously mounted to thecart 14 for ease of access to and replacement of the cartridge 40, it isalso contemplated that the cartridge holder be mounted elsewhere withinthe chamber 12, for example, to a wall of the chamber.

[0031] With particular reference to FIGS. 4-6, the base 42 of cartridgeholder 30 defines an interior chamber or well 50 for receiving thecartridge 40. In the illustrated embodiment, the base has a cylindricalportion 52 including a sidewall 54, which is closed at a lower end 55thereof by a base portion 56 and has an opening 58 at an upper end 60thereof. The cylindrical sidewall 54 has an interior surface 62 which,together with an upper surface 64 of the base portion 56, defines thewell 50. The lid 44 of the cartridge holder selectively closes theopening 58 to close the well 50.

[0032] With particular reference to FIG. 6, an annular rim 70 extendsupward from the upper end 60 of the cylindrical side wall 54 and definesan upper, horizontal annular surface 72, which extends radially inwardof the interior surface 62 of the side wall 54. A sloping surface 74extends downward and radially outward of the upper surface 72 andconnects with a vertical side surface 76 of the rim. A plurality ofradially spaced apertures 78 (twelve in the illustrated embodiment) aredefined in the sloping surface and are connected with the well bycorresponding bores 80, which extend at an angle through the rim 70(FIG. 5). The vertical surface 76 of the annular rim 70 connects withthe upper end 60 of the cylindrical portion, radially inward of an outersurface 82 of the cylindrical portion 52, to define an annularperipheral shelf 84, which slopes downwardly and radially outwardly ofthe vertical surface 76. The annular rim 70 and cylindrical portion 52of the cartridge holder base 42 may be separately formed and weldedtogether, adhesively attached, threadably connected, or otherwiseattached together. Alternatively, the rim 70 and cylindrical portion 52are integrally formed, for example by molding, with the bores 80 formedduring the molding process or subsequently thereto.

[0033] With continued reference to FIGS. 4-6, the lid 44 includes a top90 and an annular peripheral skirt 92, which depends from a peripheraledge of the top. The annular skirt 92 defines a lower surface 94 at adistal end thereof. An annular inner skirt or sealing rim 96 dependsfrom the top and is spaced inward from the annular skirt 92, such that achannel or groove 97 is defined between the peripheral skirt 92 and rim96. The inner rim 96 defines a lower surface 98 at a distal end thereof.The skirt 92 is slightly longer than the inner rim 96. When the lid 44is in the closed position, the lower surface 98 of the inner rim 96 isseated or closely adjacent to the upper surface 72 of the annular rim 70of the base. The lower surface 94 of the skirt 92 is seated above andslightly spaced from the annular peripheral shelf 84 to define anannular space or gap 100 therebetween (FIG. 5), which communicatesbetween the apertures 78 and the exterior of the cartridge, via thegroove 97. Liquid is thus able to flow from the well 50 of the cartridgeinto the reprocessing chamber 12 via the bores 80, groove 97, and gap100, even when the lid 44 is closed.

[0034] With reference once more to FIG. 3, the lid 44 is connected withthe mounting member 46 by a hinge 110. Specifically, an upper end of themounting member includes a clevis 112 with a U-shaped slot 114, whichreceives a hinge portion 116 of the cartridge lid 44 therein. The hingeportion 116 is pivotally connected to side members 118 and 120 of theclevis 112 by a hollow pivot pin 122. Specifically, the hinge portion116 and side members 118, 120 each have a bore therethrough forreceiving the pivot pin 122. As shown in FIG. 5, the pin 122 defines aninterior chamber 124 and is capped with end caps 126 at either end. Thecaps lock the pivot pin 122 to the side members 118, 120 and preventfluid flow from the ends of the interior chamber 124.

[0035] With particular reference to FIG. 1, the cartridge holder 30 isfluidly connected with a fluid distribution system 128 of thereprocessor 10. Fresh water enters the fluid distribution system 128 viaa water inlet line 130. The water is preferably pretreated to removeimpurities, such as water hardness salts, and destroy or remove harmfulorganisms. For example, the water may be sterilized, distilled,filtered, passed through an ion exchange system and/or subjected toother treatment processes before entering the reprocessor.Alternatively, or additionally, the reprocessor 10 may incorporate itsown water treatment equipment, such as a filter 132.

[0036] The fluid distribution system 128 includes a pump 140, whichpumps the water through a fluid line 142 to a manifold 144. The manifold144 is connected by fluid lines 146, 148 to upper and lower rotatingspray bars 150, 152, mounted at upper and lower ends of the chamber 12,respectively. The spray bars 150, 152 spray the water over the rack andthe items to be decontaminated. Alternatively, or additionally, otherspray means, such as nozzles (not shown), are mounted to walls of thechamber for delivering the water and disinfectant solution to thechamber 12. The water or disinfectant solution drips off the items inthe chamber and collects in a sump 154 at the base of the reprocessorchamber 12. At least a portion of the incoming water is supplied to thecartridge holder 30 to mix with the source of disinfectant and form adisinfectant solution. Specifically, the water is carried from themanifold 144 to the chamber 12 via a fluid line 156. The fluid line 156is fluidly connected with an outlet port 158 mounted in the rear wall 38of the chamber 12. A heater 160 in one of the fluid lines heats thecirculating fluid on its way to the spray bars 150, 152 or cartridgeholder 30.

[0037] With particular reference to FIG. 3, the cartridge holder 30includes a connector or cartridge inlet port 164, which extendsrearwardly from a side portion 166 of the mounting member 46 and passesthrough a suitably positioned opening in the bracket 32. The connector164 is tapered to be frictionally received within the outlet port 158when the rack 14 is pushed rearwardly into the chamber 12. Fluid flowingfrom the outlet port 158 enters the cartridge holder 30 via theconnector 164.

[0038] With reference to FIG. 5, the side portion 166 of the mountingmember 46 defines an interior fluid passage 170 which is connected at anupstream, first end 172 with the connector 164 and at a downstream,second end 174 with an aperture 176 formed in the hollow pivot pin 122,which provides access to the interior chamber 124 of the pin. The top 90of the cartridge holder lid 44 defines a second interior fluid passage178, which is connected at an upstream, first end 180 with a secondaperture 182 in the hollow pivot pin and at a downstream, second end 184with a central opening 186 in a lower surface 188 of the top 90 of thelid.

[0039] Fluid flows downstream, from the connector 164, through thecartridge holder 30 along a fluid flow path marked by arrows A (FIG. 5).Specifically, the incoming water flows through the first passage 170 andinto the interior chamber 124 of the pivot pin 122 via the first pivotpin aperture 176. The fluid flows from the interior chamber 124 and intothe second passage 178 in the lid 90 via the second pivot pin aperture182. The pump 140 supplies the water at sufficient pressure that itsprays out of the central opening 186 as a jet stream.

[0040] With reference to FIGS. 4 and 5, the cartridge 40 is positionedin the base 42 of the cartridge holder 30 prior to the start of adecontamination cycle and the lid 44 is closed. A locking assembly 190,at an opposite end of the cartridge holder from the hinge 110, is usedto lock the lid 44 to the base 42 during the decontamination cycle. Asuitable locking assembly is an overcenter clamp including an overcenterlatch 192, mounted on the base 42, which engages a catch 194, mounted onthe peripheral skirt 92 of the lid 44, although other locking membersare also contemplated.

[0041] In a preferred embodiment, best shown in FIGS. 5 and 7, thecartridge 40 includes an outer cup portion 200, formed from alightweight, rigid polymeric material, such as polyethylene, whichdefines a first interior compartment 202. The outer cup portion 200includes a generally cylindrical side wall 204 having its lower end 205closed by a snap fit, removable base portion 206. A second interiorcompartment 208 is defined in an inner cup portion 210. In the preferredembodiment, the inner cup portion includes a hemispherical peripheralwall 211, which is formed, at least in part, from a porous material. Theporous wall 211, or porous portion thereof, is permeable to water andcirculating disinfectant solution, but is impermeable to the solidchemical components within the compartments. During assembly of thecartridge 40, a porous lid or top cover 212 is sealed around itsperiphery together with flanges 214, 216 of the inner and outer cupportions 210, 200, respectively, to create the two compartments 202, 208and a composite annular cup flange 218. During a decontamination cycle,the flange 218 and rims 70, 96 cooperate to block direct fluid flow fromthe central aperture 186 to the bores 80, ensuring that all, orsubstantially all, fluid leaving the well 50 first flows through thecartridge 40. Suitable filter materials for forming the inner cupportion 208 and top cover 212 include polypropylene, polyethylene,nylon, rayon, rigid porous media, such as POREX™ expanded plastic, orother porous plastic, fabric, felt, mesh, and analogous materials.

[0042] The first compartment 202 of the cartridge 40 contains a measureddose of a first treatment material, and the second compartment 208 holdsa measured dose of a second treatment material. Preferably, the outercup portion 200 is transparent so that the contents of the cartridge 40are visible therethrough. Where the inner cup portion 210 is porous, thetreatment materials are preferably in solid form, for example, powdersor other finely divided solids, which readily disperse and dissolve inthe water. For example, the first and second treatment materials arereagents, which react in water to form a disinfectant solution.

[0043] In a preferred embodiment, the disinfectant solution includes anoxidant, preferably a peracid, such as peracetic acid. In thisembodiment, the first compartment holds a first reagent, such as aperoxy donor. Suitable peroxy donors include perborates, such as sodiummetaborate. The second compartment holds a second reagent, such as anacetyl donor. Suitable acetyl donors include acetyl salicylic acid. Thetwo reagents react in water to form the oxidant, peracetic acid in thepreferred embodiment. One or other of the compartments may additionallycontain other additives. For example, surfactants are preferablyincluded to increase removal of soil and improve penetration of thedisinfectant solution into cracks and crevices, sequestering agents areadded to combat water hardness, corrosion inhibitors reduce corrosion ofthe devices and reprocessor components by the disinfectant solution, andbuffering agents buffer the disinfectant solution to a suitable pH foroptimal disinfection.

[0044] In alternative embodiments, the cartridge 40 is configured forholding a single liquid or solid disinfectant concentrate, a liquidreagent separate from a solid reagent, two liquid reagents separately, aliquid or solid cleaning concentrate, cleaning and disinfectantconcentrates separately, or a combination cleaning/disinfectantconcentrate. The cartridge may thus comprise only a single compartment,or more than two compartments, depending on the nature of the chemicalcomponents to be accommodated. Additionally, while the cartridge 40 hasbeen described with reference to a porous inner cup portion 210, it isalso contemplated that the inner cup portion may be analogously formedto the outer cup portion, i.e., with a detachable base portion. In yetanother alternative embodiment, both the inner and the outer cupportions 200, 210 are porous or have a porous portion through whichwater and dissolved reagents flow.

[0045] With reference to FIG. 5, an opening mechanism 220 opens thecartridge to release the concentrated disinfectant or reagents forforming the disinfectant solution. In the preferred embodiment, theopening mechanism includes one or more projections extending from thecartridge holder base 56. In the illustrated embodiment, a pair ofprojections 222, 224 dislodge and push up the removable base portion 206of the cartridge as the holder lid 44 is fastened down. The projections222, 224 are preferably of unequal heights so that the detachedcartridge base portion 206 is held in an angled position, encouragingthe flow of fluid from the cartridge. The projections are attached tothe base 56 of the cartridge holder by threading threaded ends thereofinto suitably positioned threaded bores in the base 56.

[0046] In an alternative embodiment, the opening mechanism is one whichperforates or cuts a hole in the base portion 206 of the cartridge andmay be driven upwardly into the well by an actuating member (not shown),such as a ram.

[0047] In the embodiment in which the base portion of the cartridge isformed from a porous material, which allows the water and solutions topass through, the opening mechanism is eliminated.

[0048] The water dissolves the reagents or other chemical componentswithin the cartridge 40 as it passes through, thereby forming thedisinfectant solution. The disinfectant solution flows out of thecartridge via an opening 230 (FIG. 5) in the cartridge created byremoval or otherwise opening of the cartridge base portion 206. Themajority of the solution travels upward, in an annular, generallyvertically extending space 232 defined between the sidewall 204 of theouter cup portion and the interior, generally vertical surface 62 of thewell. The solution flows through the bores 80 and out of the cartridgeholder 30 via the gap 100 between the base 42 and lid 44. The solutionthus disinfects all of the surfaces of the well 50 during a microbialdecontamination cycle.

[0049] As best shown in FIG. 5, a small aperture 236 is defined in thebase 42 of the cartridge holder 30 at a lowermost portion of the well50. The aperture 236 allows solution to drain slowly from the well 50into the reprocessor chamber 12, and ensures that standing water orsolution is not left in the well at the end of the cycle.

[0050] In an alternative embodiment, the aperture 236 is wider andprovides the only outlet for the disinfectant solution from thecartridge holder. In this embodiment, the bores 80 and the gap 100 areeliminated.

[0051] A window 240 (FIG. 5) is formed in the cylindrical sidewall 54 ofthe cartridge holder base 42. The window 240 is sealed by a transparentmaterial, such as glass or plastic. This allows an operator todetermine, simply by looking through the window 240, whether a cartridge40 is positioned in the well 50 and whether the cartridge containspowder or other disinfectant concentrate. This reduces the chance thatan operator will accidentally open a cartridge holder 30 in which afresh cartridge 40 has already been installed and come into contact withthe contents of the opened cartridge.

[0052] For decontamination cycles where the items are heavilycontaminated with bioload, such as blood or other body fluids, the itemsare optionally cleaned with a cleaning solution, such as a detergentsolution or enzymatic cleaner, prior to or during the disinfection step.As shown in FIG. 1, a multi-dose dispenser 250 is optionally mountedwithin the reprocessor 10 for selectively releasing a measured dose of aconcentrated cleaner into the circulating fluids. At the start of thecycle, incoming water mixes with the cleaner concentrate to form thecleaning solution, which is delivered to the spray bars 150, 152 by thepump 140. During this cleaning step, a valve 252 in the inlet line 156to the cartridge holder 30 is optionally closed, to inhibit theformation and delivery of the disinfectant solution to the reprocessorchamber 12.

[0053] Once the cleaning solution has been circulated for sufficienttime to remove the bulk of the bioload from the items, a valve 260 in awater outlet line 262 is opened to allow the dirty cleaning solution topass from the fluid distribution system 128 to a drain. The water outletline is shown as being connected to the sump 154, although it may belocated elsewhere in the fluid distribution system 128. Additional wateris then brought into the reprocessor 10 via the water inlet line 130 andthe cartridge holder valve 252 is opened to allow the water to mix withthe chemical components in the cartridge 40.

[0054] Optionally, a detector for detecting whether the disinfectantconcentration is effective for disinfection is mounted within or isfluidly connected with the reprocessor chamber 10. The detector may be achemical indicator 264 (FIG. 1), such as a strip of paper printed withan ink which changes color on exposure to an appropriate concentrationof an oxidizing agent for a period of time judged to be sufficient toeffect disinfection or sterilization of the items within thereprocessor. Or, the detector may be a biological indicator whichcontains a population of microorganisms which show resistance to thedecontamination process. In another embodiment, a peracetic acid sensorsystem is mounted within or is fluidly connected with the reprocessorchamber 10 to provide for continuous monitoring of the peracetic acidconcentration.

[0055] With reference once more to FIGS. 1 and 2, and reference also toFIG. 8, the rack 14 is adapted to accommodate two endoscope headreceiving containers 270, 270′, generally positioned at right angles toone another, although it is contemplated that fewer or more containers270, 270′ may be accommodated. The containers 270, 270′ each define aninterior chamber (not shown) into which a head of an endoscope or otherlumened device is positioned. Disinfectant solution is supplied to thehead containers 270, 270′ by fluid lines 272 within the chamber 12. Aslight positive pressure is maintained within the head containers 270,270′ so that the fluid is forced through interior lumens of theendoscope. An insertion tube of the endoscope is positioned in a longcoiled tube 274, extending from the endoscope head receiving container270. The tube and endoscope light guide connector cord are positioned onthe rack 14.

[0056] To ensure that the pressure within the head container 270, 270′is maintained within a preselected range throughout a decontaminationcycle (i.e., high enough to ensure lumen flow but not so high as tocause damage), a pressure sensor, such as a pressure transducer 280(FIG. 1), is mounted so as to detect the pressure of the liquid withinthe endoscope head container 270, 270′. For example, the pressuretransducer 280 is mounted outside the reprocessor chamber 12 and detectspressure within each endoscope head receiving container 270, 270′ via aninterconnecting tube 282 (FIG. 1). The interconnecting tubes 282 foreach container 270, 270′ are connected with a respective port 284 on therear wall of the chamber.

[0057] With reference to FIGS. 1 and 3, the mounting member 46 of thecartridge holder 30 advantageously acts as a manifold for making otherfluid connections within the chamber 12 in addition to the waterconnection to the cartridge holder described above. For example, themounting member 46 is used to interconnect pressure tubes 290, withinthe chamber, with the connection ports 284. Each tube 290 is connectedat one end to the interior chamber of one of the endoscope headcontainers 270, 270′. Bores (not shown) within the mounting member 46each fluidly connect a first pressure connector 292, 292′, which isselectively interconnected with the respective connection port 284, withone of the tubes 290 via a second pressure connector 294, 294′,respectively. Like the connector 164, the pressure connectors 292, 292′frictionally engage and make a leak-tight or at least a substantiallyleak-tight connection with the respective port 284 when the rack 14 ispushed back into the chamber 12 prior to the start of a microbialdecontamination cycle. This reduces the number of connections anoperator has to make and ensures that one of the connections is notaccidentally overlooked.

[0058] With reference to FIG. 1, the pressure transducer 280 isconnected with a control system 296 which monitors the detectedpressures and accesses an algorithm, look-up table, or the like. If thepressure detected falls below a minimum preselected pressure or risesabove a maximum preselected pressure, the control system 296 makes aresponse. The response may be to actuate an alarm, such as a siren orflashing light (not shown), which indicates to an operator that thepressure is outside the desired range. Or, the control system 296 mayabort the cycle. In yet another embodiment, the control system 296controls the pump 140 to increase or decrease the pressure of liquiduntil the pressure within the housing is in the preselected range. Inyet another embodiment, the control system 296 controls a controllablerestrictor or valve 298 in the inlet line 272, such as a solenoid valve,to limit or increase the volume of liquid entering the endoscope headcontainer 270, 270′ in accordance with the detected pressure.

[0059] Operation of the reprocessor 10 typically proceeds as follows: Afresh single use cartridge 40 is placed in the well 50 of the cartridgeholder 30 and the lid 44 of the cartridge holder is closed. If theoperator finds the cartridge holder lid 44 is closed, a look through thewindow 240 confirms whether the cartridge holder 30 is empty. Theovercenter clamp 190 is operated to clamp the lid 44 to the base 42,clamping the flange 218 of the cartridge between the upper and lowerannular rim surfaces 98, 72. Items to be disinfected are placed on thecart 14. During loading, the cart 14 is supported by the opened door 20.The head of an endoscope to be cleaned is positioned in one of the headcontainers 270, 270′. The cart 14 is wheeled into the reprocessorchamber engaging the connectors 164, 292, 292′ with their respectiveports 158, 284. The door 20 is closed. A valve 300 in the water inletline 130 is opened and water enters the fluid distribution system 128.Once sufficient water for a decontamination step has been admitted, thevalve 300 is closed. The water is heated to a suitable temperature fordecontamination, preferably 45-55° C. in the case of peracetic acid.Water enters the cartridge holder 30 and flows through the porous top212 of the cartridge. The water mixes with the reagent in the uppercompartment 208. The water and dissolved second reagent passes throughthe porous second cup portion wall 211 and enters the lower compartment202, where the first reagent dissolves and reacts with the dissolvedsecond reagent to form the disinfectant solution. The disinfectantsolution flows out of the cartridge holder 30 and into the reprocessingchamber 12.

[0060] The pump 140 recirculates the solution from the sump 154 throughthe spray bars 150, 152, the head containers 270, 270′, and thecartridge holder 30, as discussed above. After the disinfectant solutionhas been circulated for a sufficient time to disinfect the exterior andinterior surfaces of the endoscopes and to disinfect other items in thereprocessor, the drain valve 260 in the sump 154 is opened once more andthe disinfectant solution allowed to flow into the drain line 262. Freshwater is then introduced to the reprocessor 10 via the inlet line 130,or via a separate line (not shown), which is connected with a supply ofhighly purified water, to rinse the endoscope and other items. The waterfor this step is preferably purified, to reduce the chance forrecontamination. For example, heat sterilized, micro-filtered,distilled, deionized, or other purified water is used for the rinsestep. Optionally, the rinse water is mixed with a volatile agent, suchas alcohol, to promote water removal. Finally, an air drying cycle isemployed. With reference to FIG. 1, fresh air is directed by a fan 310into the head containers 270, 270′ and optionally also into the chamber12. Preferably, the entering air or other drying gas is passed through afilter 312, such as a HEPA filter, to remove unwanted particles andmicroorganisms. The air may be heated to speed drying, although notabove a temperature which could cause damage to the endoscope or otherdevices being disinfected.

[0061] Other steps are optionally included in the cycle, or one or moreof the steps eliminated or combined. For example, separate cleaning anddisinfection steps may be performed, for example, by including separatecompartments in the cartridge which are selectively opened to releasefirst the cleaner concentrate and, subsequently, the disinfectantconcentrate. Alternatively, the cleaner concentrate is containedelsewhere in the reprocessor 10, as discussed above. One or more leaktesting steps are optionally included. For example, the endoscope isleak tested prior to being placed in the head container 270, 270′ toensure that the lumens which are intended to be leak tight do not permitwater to enter and cause damage to sensitive components duringreprocessing. Alternatively, a leak testing step may be carried outafter positioning the endoscope in the container 270, 270′, eitherbefore or after inserting the container into the reprocessor chamber. Afurther leak test may be carried out after reprocessing to ensure thatthe endoscope has not been damaged during reprocessing.

[0062] The invention has been described with reference to the preferredembodiment. Obviously, modifications and alterations will occur toothers upon reading and understanding the preceding detaileddescription. It is intended that the invention be construed as includingall such modifications and alterations insofar as they come within thescope of the appended claims or the equivalents thereof.

Having thus described the preferred embodiment, the invention is nowclaimed to be:
 1. A decontamination system comprising: a chamber forreceiving an item to be decontaminated; a cartridge holder, mountedwithin the chamber, which receives a single use cartridge containing aconcentrated decontaminant or reagents which mix with water to form adecontaminant solution, the cartridge holder including: a base whichdefines a well having an opening through which the cartridge is insertedinto the well, a lid which selectively closes the well opening, and aplurality of bores adjacent an upper end of the well which fluidlycommunicate between the well and the chamber, such that water enteringthe well is directed first through the cartridge before exiting the wellthrough the bores; and a fluid distribution system, fluidly connectedwith the cartridge holder for supplying the water to the well.
 2. Thedecontamination system of claim 1, wherein the base and lid define a gaptherebetween, radially outward of the opening, the bores fluidlycommunicating with the gap.
 3. The decontamination system of claim 1,wherein the lid includes an annular rim and the base includes an annularrim, the annular rims clamping a flange at an upper end of the cartridgetherebetween when the lid is closed.
 4. The decontamination system ofclaim 3, wherein the lid includes an annular skirt, radially outwardlyspaced from the annular rim, the annular skirt being spaced from anupper surface of the base to define a gap therebetween when the lid isclosed.
 5. The decontamination system of claim 1, further including alocking assembly which selectively locks the lid to the base.
 6. Thedecontamination system of claim 1, wherein the lid defines a first fluidpassage and an aperture which fluidly connects the fluid passage withthe well when the lid is closed.
 7. The decontamination system of claim6, wherein the lid is pivotally connected with the base by a hinge andwherein the hinge defines a second fluid passage therethrough which isfluidly connected with the first fluid passage.
 8. The decontaminationsystem of claim 6, further including a fluid connector, mounted to thecartridge holder, the connector being configured for selectivelyinterconnecting the second fluid pathway with a fluid port of the fluiddistribution system.
 9. The decontamination system of claim 1, furtherincluding a rack for supporting the items, the rack being movablebetween a first position, in which items are loaded onto the rack, and asecond position, in which the rack is positioned within the chamber, thecartridge holder being carried by the rack.
 10. The decontaminationsystem of claim 9, wherein the cartridge holder includes a connectorfluidly connected with the well by a passageway in the cartridge holder,the connector being selectively connectable with a fluid port of thefluid distribution system when the rack is moved to the second position.11. The system of claim 10, wherein the cartridge holder includes asecond connector for selective interconnection with a second fluid port,the system further including: a container carried by the rack forreceiving a portion of the item; a fluid line fluidly connecting thecontainer and the connector for fluidly interconnecting the containerwith the second port when the rack is moved to the second position. 12.The system of claim 11, wherein the second fluid port is fluidlyconnected with a pressure detector for detecting the fluid pressurewithin the container.
 13. The decontamination system of claim 1, furtherincluding: a pump fluidly connected with the fluid distribution system,and spray means, mounted within the chamber and fluidly connected withthe fluid distribution system, for spraying the decontaminant solutionover the item.
 14. The system of claim 1, further including: an apertureat a lower end of the base, through which disinfectant solution drainsfrom the well into the chamber.
 15. The system of claim 1, furtherincluding: a window, defined in the base, through which the cartridge isvisible when the lid is closed.
 16. A cartridge holder comprising: abase which defines a well for receiving a cartridge having a side wall,the base having an opening adjacent an upper end thereof, the baseincluding a plurality of bores which extend from the well to an exteriorsurface of the base adjacent the opening; a lid which selectively closesthe opening; and a fluid passageway at least partially defined by thelid which is fluidly connected with the well.
 17. The cartridge holderof claim 16, further including: a hinge which pivotally connects the lidand the base, the hinge including a pivot pin which defines an interiorchamber, the interior chamber forming a part of the fluid passageway.18. A method of disinfection comprising: placing a cartridge in a welldefined by a base through an opening in the well, the cartridge having aside wall and upper and lower ends which selectively hold within thecartridge a disinfectant concentrate or reagents which react in a liquidto form a disinfectant solution; closing the opening in the well with alid; supplying the liquid to the well; flowing the liquid into thecartridge through the upper end such that the liquid mixes with theconcentrate or reagents to form the disinfectant solution; flowing thedisinfectant solution out of the cartridge into the well through thelower end of the cartridge; flowing the disinfectant solution through aspace between the cartridge side wall and the well to disinfect thewell; flowing the disinfectant solution out of the well through bores inthe base adjacent an upper end of the well; and contacting items to bedisinfected with the disinfectant solution.
 19. The method of claim 18,further including: flowing the liquid into the well through a passagewayat least partially defined through the lid.
 20. The method of claim 19,wherein the lid is pivotally connected to the base by a hinge, and thepassageway is at least partially defined in the hinge.
 21. The method ofclaim 18, further including: draining a portion of the disinfectantsolution through a hole at a lower end of the well.
 22. The method ofclaim 18, wherein the well is fluidly connected with a connector, theconnector being carried by a movable rack, the method further including:wheeling the rack into a chamber, the connector automatically connectingwith a fluid outlet port within the chamber as the rack is wheeled intothe chamber.
 23. The method of claim 18, wherein the step of closing theopening includes clamping an annular flange at an upper end of thecartridge between a first surface defined by the base and a secondsurface defined by the lid, the bores defining openings which areradially outwardly spaced from the first surface, such thatsubstantially all liquid leaving the well passes through the cartridge.